Add-on Effectiveness of EA or TENS in Early Postpartum Breast Engorgement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-12

Study Completion Date

2019-07-31

Brief Summary

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A total of 36 volunteers of postpartum women within 7 days with significant breast engorgement, will be recruited in China Medical University Hospital, Taichung, Taiwan. The participants will be randomly assigned into 3 groups, each of 12 people, namely, routine care group, routine care plus electrical-acupuncture experiment group, and routine care plus transcutaneous electrical nerve stimulation group.

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Detailed Description

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Participants will receive once a day, three consecutive days of interventions in each group, including identical routine care. On each visit, severity index (SI) subject to the extent of erythema, tension and pain over breast will be assessed. Questionnaires of Breastfeeding Self-Efficacy Scale (BSES-SF) and of Edinburgh postnatal depression scale (EPDS) will be performed. Heart-rate variability was evaluated and recorded via a real-time handheld HRV device. Oxycontin, Cortisol, sodium and potassium levels in breastmilk will be tested . A telephone follow-up will be performed in 30 days after completion of treatment, and the data will be collected and analyzed.

Conditions

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Breast Engorgement in Puerperium Post Partum Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Routine care

Routine care for early postpartum breast engorgement, including reverse pressure technique over areola, along with hand expression of breastmilk.

Group Type EXPERIMENTAL

Routine care

Intervention Type OTHER

Reverse pressure applied to the areola

Routine care plus EA

Routine care for early postpartum breast engorgement, including reverse pressure technique over areola, along with hand expression of breastmilk.

plus: Electrical acupuncture on body acupoints

Group Type EXPERIMENTAL

Routine care

Intervention Type OTHER

Reverse pressure applied to the areola

Electrical Acupuncture

Intervention Type PROCEDURE

Acupuncture on Hegu, Sanyinjiao, Zusanli and Taichong with electrical stimulation

Routine care plus TENS

Routine care for early postpartum breast engorgement, including reverse pressure technique over areola, along with hand expression of breastmilk.

plus: Transcutaneous electrical nerve stimulation on breasts

Group Type EXPERIMENTAL

Routine care

Intervention Type OTHER

Reverse pressure applied to the areola

Transcutaneous Electrical Nerve Stimulation

Intervention Type PROCEDURE

Transcutaneous electrical nerve stimulation over bil breasts

Interventions

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Routine care

Reverse pressure applied to the areola

Intervention Type OTHER

Electrical Acupuncture

Acupuncture on Hegu, Sanyinjiao, Zusanli and Taichong with electrical stimulation

Intervention Type PROCEDURE

Transcutaneous Electrical Nerve Stimulation

Transcutaneous electrical nerve stimulation over bil breasts

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Gestational age \> 37 wk
* Delivery of singleton, healthy newborn baby
* Within 7 days postpartum
* Within 24 hours from initial painful breast engorgement
* Difficulty on lactation due to plugged ducts, SI index ≧ 5 (0-19)

Exclusion Criteria

* Fever\>37.5∘C
* Mastitis or breast abscess
* Signs of sepsis or other infection
* Perinatal mother and infant diseases (Gestational hypertension、Gestational Diabetes Mellitus、Pre-eclampsia 、Gestational thyroid diseases or Intrauterine growth retardation)
* Psychological diseases
* Bleeding tendency
* Artificial valves
* Pacemaker
* Epilepsy
* Consciousness disturbance
* Skin infections
* Hepatitis B carrier
* Acquired Immune Deficiency Syndrome
* Breast tumors
* Breast Surgeries

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No